Evaluation of the Surgical Proficiency and Effectiveness of the Acumed Scapholunate Repair System in Primary Scapholunate Instability Among Canadians

PHASE1UnknownINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

January 31, 2023

Primary Completion Date

September 30, 2025

Study Completion Date

September 30, 2025

Conditions
Complete Tear of Scapholunate LigamentScapholunate Dissociation
Interventions
DEVICE

ACUMED® Scapholunate Repair System Group

To address the technical difficulties associated with the RASL procedure, Dr. Mel Rosenwasser developed an external over-the-top jig that in theory enables accurate and easy scapholunate-axis screw placement. The Acumed Scapholunate Repair System was designed treat patients with acute or chronic, static or dynamic scapholunate instability in the absence of significant capitolunate osteoarthritis, scapholunate ligament repair, scapholunate reduction, lunotriquetral ligament repair, lunotriquetral reduction, and carpal instability. This new Scapholunate Repair System features a targeting guide designed to enable the surgeon to reproducibly place the implant in optimal position. The implant allows physiologic intercarpal scapholunate rotation by means of a free rotation design. The procedure can forestall progressive osteoarthritis and the need for secondary salvage procedures.

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Acumed, LLC

INDUSTRY

lead

University of Calgary

OTHER

NCT04980547 - Evaluation of the Surgical Proficiency and Effectiveness of the Acumed Scapholunate Repair System in Primary Scapholunate Instability Among Canadians | Biotech Hunter | Biotech Hunter